The letter, issued on August 15, was later made public by the USFDA, which stated that there was failure to ensure the accuracy of data in records for both production and process simulations, i.e. media fills. Media fill is a microbiological test to help prevent contamination during drug production.
“Your procedure requires testing of all (b)(4). While you documented testing of all of the (b)(4), your operators did not test all of the (b)(4) used during manufacturing of sterile injectable drug products,” the USFDA stated.
It also pointed out that operators falsifying environmental monitoring records of multiple aseptic filling lines. “These systemic data integrity issues involved numerous production and quality assurance staff and were occurring at your facility for multiple months.”
